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Trial registered on ANZCTR


Trial ID
ACTRN12613000584730
Ethics application status
Approved
Date submitted
16/05/2013
Date registered
24/05/2013
Date last updated
9/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a traditional Persian medicine syrup (Jollab) on Functional Dyspepsia patients
Scientific title
Survey on a traditional Iranian medicine syrup (Jollab) in relieving gastrointestinal symptoms in Functional Dyspepsia (FD) patients: a randomized double-blind placebo-controlled clinical trial
Secondary ID [1] 282518 0
None
Universal Trial Number (UTN)
U1111-1143-1766
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional Dyspepsia 289181 0
Condition category
Condition code
Oral and Gastrointestinal 289502 289502 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Alternative and Complementary Medicine 289571 289571 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A traditional Persian medicine syrup named Jollab, is administered orally 3 times daily, 45 milliliters totally, during 4 weeks. this syrup is a combination of distilled water, Rose water, Saffron and Sugar as mentioned in Avicenna's book (Al-Qanoon fil-teb). As the active agents have synergistic effect, there isn't way to specify the active ingredients amount.
In order to monitor adherence, patient should check a form and render this form in follow-up meetings.
Intervention code [1] 287178 0
Treatment: Other
Comparator / control treatment
A combination of distilled water, Standard dye material and 5% Rose water
Control group
Placebo

Outcomes
Primary outcome [1] 289607 0
Relief in Gastrointestinal symptoms in functional dyspepsia patients assessed by Leeds Questionaire
Timepoint [1] 289607 0
0- Baseline
1- At two weeks after the beginning of trial
2- At one month after the beginning of trial
3- At two months after the beginning of trial
Secondary outcome [1] 302839 0
Depression as assessed using Beck Questionaire
Timepoint [1] 302839 0
Baseline, and at 4 weeks after the beginning of intervention
Secondary outcome [2] 302842 0
Quality of life as assessed using SF-36 Questionaire
Timepoint [2] 302842 0
Baseline, and 2 months after the beginning of intervention

Eligibility
Key inclusion criteria
1- Functional Dyspepsia (FD) patients according to Rome III criteria, based on general exam and gastrointestinal endoscopy
2- Normal range of lab data (CBC, LFT, Stool exam)
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- Steatorrhoea 2- Celiac disease 3- Night Diarrhea 4- Beginning of FD after the age of 40 years 5- Cancer (any form) 6- Liver disease 7- Pulmonary disease 8- Auto-immune disease 9- Psychiatry disease 10- pregnancy 11- Lactation 12- Irritable Bowl Syndrome (IBS) 13- History of Abdominal Surgery 14- Treatment with Lactolose or similar drugs 15- Consumption of drugs contributed to FD simultaneously 16- Consumption of Analgesic or Narcotic drugs

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5084 0
Iran, Islamic Republic Of
State/province [1] 5084 0
Fars

Funding & Sponsors
Funding source category [1] 287300 0
University
Name [1] 287300 0
Shahid Beheshti University of Medical Science
Address [1] 287300 0
Tehran State,
Tehran,
Velenjak Str. , Shahid Chamran Highway,
Postcode: 1985717443
Country [1] 287300 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Shahid Beheshti University of Medical Science
Address
Tehran State,
Tehran,
Velenjak Str. , Shahid Chamran Highway,
Postcode: 1985717443
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 286053 0
None
Name [1] 286053 0
Address [1] 286053 0
Country [1] 286053 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289276 0
Shahid Beheshti University of Medical Science Ethics Committee
Ethics committee address [1] 289276 0
Tehran State,
Tehran,
Velenjak Str. , Shahid Chamran Highway,
Postcode: 1985717443
Ethics committee country [1] 289276 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 289276 0
Approval date [1] 289276 0
Ethics approval number [1] 289276 0

Summary
Brief summary
Functional Dyspepsia (FD) is a widespread disease in community. The pathophysiology of Fd is not clearly evident, yet. The disease has a huge expense for health system and the treatments aren't sufficient unfortunately.
Traditional Persian Medicine originated from the knowledge of great physicians like Avicenna, presented herbal drugs which have been used by people for hundreds years.
An inexpensive accessible Persian herbal syrup named as Jollab has been introduced in Traditional Persian Medicine books repeatedly.
The aim of this study is to evaluate the efficacy of Jollab in relieveing symptoms of FD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40130 0
Dr Mehdi Pasalar
Address 40130 0
Postal Code:71888-37187
no. 2
Nikan Building,
Lane 21/2,
Mirzay-e-Shirazi Bulvard,
Shiraz
Shiraz University of Medical Sciences
Country 40130 0
Iran, Islamic Republic Of
Phone 40130 0
+989173121345
Fax 40130 0
Email 40130 0
pasalar@sums.ac.ir
Contact person for public queries
Name 40131 0
Dr Mehdi Pasalar
Address 40131 0
Postal Code:71888-37187
no. 2
Nikan Building,
Lane 21/2,
Mirzay-e-Shirazi Bulvard,
Shiraz
Shiraz University of Medical Sciences
Country 40131 0
Iran, Islamic Republic Of
Phone 40131 0
+989173121345
Fax 40131 0
Email 40131 0
pasalar@sums.ac.ir
Contact person for scientific queries
Name 40132 0
Prof Kamran Bagheri Lankarani
Address 40132 0
Shiraz University of Medical Sciences,
Health policy Research Center, Building No 2, Eighth Floor, School of Medicine, Zand Avenue, Shiraz, Iran, Postal code: 7134853185
Country 40132 0
Iran, Islamic Republic Of
Phone 40132 0
+987112309615
Fax 40132 0
Email 40132 0
lankaran@sums.ac.ir